The Alma Lasers Accent is a console with three previously cleared RF hand piecesand one ultrasound hand piece that is the subject of this submission. The previouslycleared hand pieces have not changed from what was cleared in their associated 510(k)submissions. The new ultrasound hand piece is a therapeutic ultrasound hand piece with afrequency of 1 MHz using a 1.2 cm2 transducer. The touch screen on the console showsthe treatments that have been chosen and when the output is active.

The Alma Lasers Accent is a console with three previously cleared RF hand pieces and one ultrasound hand piece that is the subject of this submission. The previously cleared hand pieces have not changed from what was cleared in their associated 510(k) submissions. The new ultrasound hand piece is a therapeutic ultrasound hand piece with a frequency of 1 MHz using a 1.2 cm2 transducer. The touch screen on the console shows the treatments that have been chosen and when the output is active.

The Alma Lasers Accent is a console with three previously cleared RF hand pieces and one ultrasound hand piece that is the subject of this submission. The previously cleared hand pieces have not changed from what was cleared in their associated 510(k) submissions. The new ultrasound hand piece is a therapeutic ultrasound hand piece with a frequency of 1 MHz using a 1.2 cm2 transducer. The touch screen on the console shows the treatments that have been chosen and when the output is active.

The Alma Lasers Accent is a console with three previously cleared RF hand pieces and one ultrasound hand piece that is the subject of this submission. The previously cleared hand pieces have not changed from what was cleared in their associated 510(k) submissions. The new ultrasound hand piece is a therapeutic ultrasound hand piece with a frequency of 1 MHz using a 1.2 cm2 transducer. The touch screen on the console shows the treatments that have been chosen and when the output is active.

Opus Colibri 0.7mm Single-use Tip one ubit

Opus Colibri 1mm Single-use Tip one unit

Opus Colibri 1mm Single-use Tip Set of 6 units

Opus Colibri 0.7mm Single-use Tip Set of 6 units

Glide Disposable Tip Set of 12 units

Glide Disposable Tip one pc.

(includes Glide Disposable Tip Set (X12) & Opus Plasma Tip Kit)

Refurbished ,Vela- Pack. 115Vac Assy

VelaSmooth Large Applicator Packaged

Refurbished ,Vela- Pack.100Vac Assy

Vela SA Appl.Pack.+ Disp.Parts for Appl.

Repl. Cover (Dark Gray), SA-8Hr, VelaShape II

Repl. Cover,(White) LA-8Hr, Stacking, Vela Shape II

Repl. Cover,(White) LA-16Hr, Stacking, Vela Shape II

Vsmooth Applicator (LA), Packaged

Vcontour Applicator (SA) ,Packaged

VelaShape System 100V, Packaged

Small Applicator, VelasmoothPro

Large Applicator, VelasmoothPro

VelasmoothPro System 115V, Packaged

VelasmoothPro System 100V, Packaged

VelaSmooth Large Applicator (H)

Vela Shape II System 115V, Packaged

Vela Shape II System 100V, Packaged

Vsmooth Applicator (LA), VelaShape II

Vcontour Applicator (SA), VelaShape II

VelaShape III System 120V, Packaged

LA Repl. Cvr. (1Hr) 10-Pk, VelaShape II

SA Repl. Cvr. (1Hr) 10-Pk, VelaShape II

LA Repl. Stacking Covers (8 Hr) 5-Pk, VelaShape II

LA Repl. Stacking Covers (16 Hr) 10-Pk, VelaShape II